Biomechanical Gait Analysis in Patients Post-Stroke

NCT03602313 | Completed

• 1 other identifier: 2011-40
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

Randomized trial of patients with cerebrovascular accident (CVA) receiving traditional and body weight supported (BWS) gait training. Participants are enrolled and randomized upon entry into acute care and gait is evaluated within 48 hours of discharge from the rehabilitation hospital. Gait analysis is used to determine which of the two groups achieved gait parameters most similar to the normal gait of an age-matched population.

Conditions

CVA (Cerebrovascular Accident); Stroke

Keywords

Body Weight Support

Outcome Measures

Primary Outcomes (4)

• Gait Speed

  Velocity of center of mass of the participant.

  Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days.

• Step Length

  Difference in position between the feet at heel strike, in the direction of forward motion.

  Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days.

• Step Width

  Difference in position between the feet at heel strike, in the direction normal to the direction of forward motion.

  Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days.

• Step Asymmetry

  The ratio of the difference of left and right step length over the stride length.

  Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days.

Secondary Outcomes (3)

• Gait Units

  Measured at discharge, approximately 21 days

• Functional Independence Measure (FIM)

  Admission of the FIM is completed within 72 hours of the start of a rehabilitation, and within 75 hours of discharge, approximately 21 days

• Length of Stay

  Approximately 21 days. Determined by the study clinicians based on severity of disability and rate of progress.

Study Arms (2)

Traditional Gait Training

ACTIVE COMPARATOR

The Traditional Gait Training group will receive gait training as presently performed without additional modalities.

Other: Traditional Gait Training

Body Weight Support Training

EXPERIMENTAL

The Body Weight Support group will received body weight support gait training in lieu of traditional gait training.

Device: Body Weight Support Gait Training

Interventions

Body Weight Support Gait Training DEVICE

Also known as: BSWTT, LiteGait

Body Weight Support Training

Traditional Gait Training OTHER

Also known as: Overground

Traditional Gait Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current in-patient in acute care for Cerebrovascular accident (CVA),
• Unilateral CVA affecting at least the lower limb, and
• Medically stable as determined by the rehabilitation physician.

You may not qualify if:

• Previous (more than 1) CVA with residual lower limb deficit, and
• Any lower extremity pathology on the affected side other than the effects of the CVA.

Sponsors & Collaborators

• Florida Gulf Coast University: lead

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Derek J Lura, PhD

  Florida Gulf Coast University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigators were blinded to the study intervention. Data collection was performed at a separate location than the primary intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were randomly assigned to 1 of 2 groups for the duration of the study.

Study Record Dates

• First Submitted: May 4, 2018
• First Posted: July 26, 2018
• Study Start: December 6, 2011
• Primary Completion: September 17, 2015
• Study Completion: September 17, 2015
• Last Updated: July 26, 2018

Record last verified: 2018-07